Cagrilintide is a long-acting amylin analogue under clinical investigation for obesity and type 2 diabetes, including development as part of the cagrilintide/semaglutide combination. Current evidence reflects research-stage use rather than approved routine clinical use.
The FDA has announced plans to crack down on active pharmaceutical ingredients used in compounded GLP-1 drugs and warned about the risks of these products. The agency has cited counterfeit products, non-FDA-approved ingredients and more than 1,000 adverse event reports tied to compounded semaglutide and tirzepatide.
Semaglutide and tirzepatide represent distinct GLP-1-based weight management medications with different mechanisms of action. Clinical trials show varying weight loss outcomes, while new combination therapies undergo head-to-head testing.
Novo Nordisk's next-generation obesity drug CagriSema achieved 23% weight reduction compared to 25.5% for Eli Lilly's tirzepatide in an 84-week trial, causing Novo shares to fall 15% and raising questions about its competitive position.
CagriSema demonstrated 23% weight loss in the REDEFINE 4 trial but failed to meet its primary endpoint of non-inferiority compared to tirzepatide's 25.5% weight loss. The company submitted an FDA application in December 2025 based on earlier pivotal trials.
Novo Nordisk's next-generation obesity drug CagriSema achieved 23% weight reduction compared to 25.5% for Eli Lilly's tirzepatide in an 84-week trial, sending Novo shares down 15% and erasing over $400 billion in market value since 2024.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07557953 |
A Research Study Looking Into How Cagrilintide Influences Food Intake and Appetite in People With Overweight or Obesity |
RECRUITING | PHASE1 |
| NCT07527195 |
Understanding the Effect of CagriSema, Cagrilintide, and Semaglutide on Muscle Health (Role of Amylin Signature in Muscle Health) |
RECRUITING | PHASE1 |
| NCT07411560 |
A Study Looking at How Weekly Injections of Two Hormones - GIP and Amylin - Affect Stomach-related Side Effects in People Who Are Overweight or Obese |
RECRUITING | PHASE1 |
| NCT07253285 |
A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight |
RECRUITING | PHASE3 |
| NCT07220759 |
Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT07220642 |
Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT07010432 |
The Role of the Amylin Analogue Cagrilintide in Bone Metabolism |
RECRUITING | PHASE1 |
| NCT06780449 |
A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT06534411 |
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT06409130 |
Effects of NNC0194-0499, Cagrilintide, and Semaglutide Alone or in Combinations on Liver Damage and Alcohol Use in People With Alcohol-related Liver Disease |
COMPLETED | PHASE2 |
